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PDS Tech Inc Document Control Analyst/ Labeling Specialist in Middletown, Virginia

PDS Tech, Inc. is seeking a Document Control Analyst/ Labeling Specialist in Middleton, VA.

Position Summary:

  • Manage and track all IVDR project labeling tasks, provide status and work with internal Subject Matter Experts (SMEs) to make required changes before implementation due date

  • Create, prepare artwork for labels/inserts and newly created documents for client products

  • Assist with the formatting of Product Master Records (PMRs) to align with the new template in Master Control

  • Control of the documents that include Product Master Records, Batch Records, Forms and SOPs as required by GMP including trial documents

  • Creates production and testing documentation, new and revised, in accordance with GMP/QSR requirements

  • Initiates and coordinates Change Orders. * Controls and maintains Departmental Databases for PMR and specification changes

  • Assists in updating and maintaining plant system databases (including but not limited to: MRP, Master Control, Bartender & InDesign)

  • Proofreads corrections made to documents

  • Maintains complete and accurate files of documents under the change control of the Documentation Department as required by GMP

  • Update and maintain template library via Master Control

  • Collate data from various departments and enter metric monitoring system for the site. Construct and disseminate KPI reports

  • Writes Standard Operating Procedures (SOPs), Work Instructions (WI), Training Summary Forms (TSFs), and Change Orders (Cos)

  • Assist with Corrective and Preventative Actions, as assigned

  • Performs other duties as assigned

Minimum Requirements/Qualifications:

  • High School Degree required

  • College degree preferred

  • 2+ years relevant experience required in product label generation

  • Knowledge of scientific terminology, medical or pharmaceutical manufacturing processes and GMP desirable

  • Knowledge of in vitro diagnostic processes highly desired


  • This position may require up to 5% travel, some of which will take place outside of the typical office hours

Physical Requirements:

  • Normal office environment

  • Position may require frequent communication and walking to other areas in which designated PPE will be required

  • Majority of time will be spent manipulating data at computer, sitting, reaching, bending, and twisting

  • Employee may occasionally lift and/or move up to 50 pounds

Non-Negotiable Hiring Criteria:

  • Intermediate to advanced word-processing skills; spreadsheet and database skills a plus (Microsoft Office preferred)

  • Proficiency in documentation best practices, typing, proofreading and editing required

  • Ability to interact with and provide training to all levels of staff, internal and external customers and vendors

  • Strong oral and written communication skills. * Excellent organization skills and ability to manage multiple requests/projects, along with rapidly changing priorities

  • Team player with good interpersonal skills

  • Ability to exercise good judgment and be able to make decisions within prescribed guidelines

  • Must demonstrate good safety and quality control

  • Must be a self-starter with the ability to work independently; requiring little or no supervision

  • Attention to detail

  • Professional and courteous attitude

  • Ability to identify, recommend and implement major process improvements

  • Willingness to be flexible

  • Ability to multi-task

  • Demonstrate proficiency in multiple team specific processes

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.